Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02675881
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.2
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.

Condition or Disease	Intervention/Treatment	Phase
HCC; Metastasis	Device: DSM; Device: separable clustered electrode	N/A

Detailed Description

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study
• Actual Study Start Date: Aug 5, 2013
• Actual Primary Completion Date: Apr 8, 2015
• Actual Study Completion Date: Jul 13, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RFA DSM Eligible patients who undergo RFA using DSM and separable clustered electrodes.	Device: DSM; Monopolar RFA using dual switching mode (DSM); Device: separable clustered electrode; A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.; Other Names: Octopus(R)
No Intervention: RFA SSM Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.

Outcome Measures

Primary Outcome Measures

1. local tumor progression (LTP) [12 months]

Secondary Outcome Measures

1. Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor) [1 months]

2. rate of intrahepatic distant recurrence (IDR) after RFA [12 months]

3. rate of extrahepatic metastasis (EM) after RFA [12 months]

Other Outcome Measures

1. Number of complication of RFA [6 months]

   incidence of any possible complication related with RFA

2. Maximal diameter of ablative zone [7 day]

   Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.

3. ablation time [1 day]

   ablation time in a patient

4. Real time US fusion image feasibility [1 day after RFA procedure]

   success or failure of accurate fusion between US and pre-RFA cross sectional images

5. Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration. [12 months]

   Prediction of LTP by classifying patients according to assessing ablative margin in each method on a four point scale (1: residual tumor, 4: ablative margin equal to or larger than 5mm)

6. Volume of ablative zone [7 days]

   Volume of ablative zone on post-RFA CT or MRI in a mm3.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)

• histologically confirmed HCC

• histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND

• equal to or larger than 2cm, equal to or smaller than 5cm

• available cross-sectional liver imaging within 30 days before RFA

• signed informed consent

Exclusion Criteria:

• history of local treatment on the index tumor

• more than three tumors in a patient

• tumors in central portion of portal vein or hepatic vein

• Child-Pugh class C

• vascular invasion by tumors

• uncorrected coagulopathy

• presence of multiple extrahepatic metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02675881
• Other Study ID Numbers: SNUH-2013-1441
• First Posted: Feb 5, 2016
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital: RFA
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Mar 18, 2021